Erlotinib hydrochloride composition tablet and preparation method thereof

A technology of erlotinib hydrochloride and its composition, which is applied in the field of erlotinib hydrochloride composition tablet and its preparation, can solve problems affecting stability and the like, and achieve improved safety, high dissolution rate, and controllable quality Effect

Inactive Publication Date: 2016-07-13
DEYANG HUAKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, a large amount of silicon dioxide is used, and the preparation is easy to absorb moisture, which affects the stability of the product.

Method used

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  • Erlotinib hydrochloride composition tablet and preparation method thereof
  • Erlotinib hydrochloride composition tablet and preparation method thereof
  • Erlotinib hydrochloride composition tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The preparation method of the above -mentioned Elotininini hydrochloride hydrochloric acid, including the following steps:

[0043] Step 1: Smoothylhutinin crystals with pre -intersecting starch, calcium sulfate, and sodium cross -linked carboxymethyl starch at 500R / min, mix well, crushed, over 100 destination sieve, obtain 100 destination mixture particlesIt

[0044] Step 2: Add the purified water and ethanol with a volume ratio of ethyl cellulose, β-cyclic paste, and vomiting temperature to 1: 2, stir well to get granular liquid, add the grain liquid to the mixture particles, and stir well.Filter and granulate, get wet particles, dry the dry particles at 80 ° C to get dry particles, control dry particles to free water ≤1.2 %;The weight ratio of a pure water and ethanol with a volume ratio of the base cellulose to the volume is 1: 2;

[0045] Step 3: Add sodium ricimate and microfiflo silicone to the 40 -purpose dry particles, stir well to get the mixture;

[0046] Step 4....

Embodiment 2

[0049] The preparation method of the above -mentioned Elotininini hydrochloride hydrochloric acid, including the following steps:

[0050] Step 1: Sodium Elotinib crystals hydrochloride and pre -intersecting starch, calcium sulfate, and sodium cross -linked carboxymethyl starch at 300r / min, mix well, crushed, and over 200 destination sieves, obtained 200 destination mixture particles granulesIt

[0051] Step 2: Add the purified water and ethanol with a volume ratio of ethyl cellulose, β-cyclic paste, and vomiting temperature to 1: 4, and stir well to get the grain liquid.Inside, the high -voltage power supply was applied to the high -voltage power supply on the stainless steel sprinkler, and the granular liquid was sprayed from the stainless steel sprinkler to the receiving device of the strong mixture particles.Dry the dry particles at 60 ° C, control dry particles to free water ≤1.2 %; the dry particles sieved over 60 destinations to obtain 60 destinations;The weight ratio of wa...

Embodiment 3

[0056] The preparation method of the above -mentioned Elotininini hydrochloride hydrochloric acid, including the following steps:

[0057] Step 1. Add the weight ratio to 1: 4, Elotinininibicin and polymethyl acrylic methyl ester to the second methyl sub -sarne solution, heat and stir until it is fully dissolved, obtain a mixture solution, input the mixture solution to the application to the applicationIn the stainless steel sprinkler with voltage, high -voltage static electricity is applied through a high -voltage power supply on the stainless steel sprinkler, and the mixture solution is sprayed from the stainless steel sprinkler to the volume ratio of 50 ° C in the volume ratio of 1: 1 methanol and water receiving device.After completion, stir for 2 hours, filter, the filter fluid at a frequency of 25kHz and the output power of 40W, cool at 5 ° C / hour to -5 ° C, raise crystal for 3 hours, wash, vacuum dry, get Hydrochloride Elotoen, get Hydrochloride Disari, get the hydrochloric...

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Abstract

The invention discloses an erlotinib hydrochloride composition tablet and a preparation method thereof. The erlotinib hydrochloride composition tablet comprises the following ingredients in percentage by weight: 20-38% of erlotinib hydrochloride crystals, 30-50% of pregelatinized starch, 25-45% of calcium sulfate, 1-5% of ethyl cellulose, 6-12% of beta-cyclodextrin, 0.2-3% of Tween, 5-10% of crosslinked sodium carboxymethyl starch, 0.5-1.5% of sodium stearyl fumarate and 0.2-2% of micropowder silica gel. A preparation process route of the erlotinib hydrochloride composition tablet is stable, simple and easy to operate, set technological parameters can effectively control each reaction, and sample detection results show that an erlotinib hydrochloride crude drug is stable in crystal form and relatively good in purity and quality requirements of a final product can be met. A synthesis and production technology of the erlotinib hydrochloride composition tablet is simple, stable and feasible and is applicable to mass production; and quality is controllable, and stability is relatively good.

Description

Technical field [0001] The present invention is a pharmaceutical preparation technology field, which involves a combination of Elotinininhin hydrochloride and its preparation methods. Background technique [0002] In the past half century, the incidence and mortality rate of lung cancer have increased year by year. In the early 20th century, lung cancer was still a rare disease. By the end of the 20th century, lung cancer had accounted for the first of malignant tumors.According to regular information released by the World Health Organization (WHO), the incidence and mortality of lung cancer have significantly increased in countries around the world, especially industrial developed countries.There are more than 2 million new lung cancer patients in the world and more than 1 million deaths; more than 500,000 new lung cancer patients each year in my country and more than 300,000 deaths.At present, lung cancer has replaced liver cancer as the first cause of malignant tumor death in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/517A61P35/00C07D239/94
CPCA61K9/2866A61K9/2059A61K9/2095A61K31/517C07B2200/13C07D239/94
Inventor 邓强李维黄晓平李开均
Owner DEYANG HUAKANG PHARMA
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